RT Journal Article SR Electronic T1 A comprehensive assessment of 68Ga-PSMA-11 PET in biochemically recurrent prostate cancer: Results from a prospective multi-center study in 2005 patients JF Journal of Nuclear Medicine JO J Nucl Med FD Society of Nuclear Medicine SP jnumed.121.262412 DO 10.2967/jnumed.121.262412 A1 Monica Abghari-Gerst A1 Wesley Robert Armstrong A1 Kathleen Nguyen A1 Jeremie Calais A1 Johannes Czernin A1 David Lin A1 Namasvi Jariwala A1 Melissa Rodnick A1 Thomas A. Hope A1 Jason Hearn A1 Jeffrey S. Montgomery A1 Ajjai Alva A1 Zachery R. Reichert A1 Daniel E. Spratt A1 Timothy D. Johnson A1 Peter J.H. Scott A1 Morand Piert YR 2021 UL http://jnm.snmjournals.org/content/early/2021/08/26/jnumed.121.262412.abstract AB We prospectively investigated the performance of the prostate-specific membrane antigen (PSMA) ligand 68Ga-PSMA-11 for detecting prostate adenocarcinoma in patients with elevated prostate-specific-antigen (PSA) after initial therapy. Methods: 68Ga-PSMA-11 hybrid positron emission tomography (PET) was performed in 2005 patients at the time of biochemical recurrent prostate cancer (BCR) following either radical prostatectomy (RP) (50.8 %), definitive radiation therapy (RT) (19.7 %), or RP with post-operative RT (PORT) (29.6 %). Presence of prostate cancer was assessed qualitatively (detection rate = positivity rate) and quantitatively on a per-patient and per-region basis creating a disease burden estimate from presence or absence of local (prostate/prostate bed), nodal (N1: pelvis) and distant metastatic (M1: distant soft tissue and bone) disease. The primary study endpoint was the positive predictive value (PPV) of 68Ga-PSMA-11 PET/CT confirmed by histopathology. Results: Following prostatectomy, the scan detection rate increased significantly with rising PSA levels (44.8 % at PSA < 0.25 to 96.2 % at PSA > 10 ng/mL; P < 0.001). The detection rate significantly increased with rising PSA levels in each individual region, overall disease burden, prior androgen deprivation, clinical T-stage, and Gleason grading from prostatectomy specimen (P < 0.001). Following RT, the detection rate for in-gland prostate recurrence was 64.0 % compared to 20.6 % prostate bed recurrences after RP and 13.3 % following PORT. PSMA-positive pelvic nodal disease was detected in 42.7 % following RP, in 40.8 % after PORT and 38.8 % after RT. In patients with histopathologic validation the PPV per-patient was 0.82 (146/179). The SUVmax of histologically proven true positive lesions was significantly higher than false positive lesions (median 11.0 (IQR 6.3 – 22.2) vs 5.1 (IQR 2.2 – 7.4) P < 0.001). Conclusion: We confirmed a high PPV of 68Ga-PSMA-11 PET in BCR and the PSA level as the main predictor of scan positivity.